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BRYAN® Cervical Disc. Caution: Investigational device. Limited by federal (or United States ) law to investigational use. BRYAN® Cervical DiscThe surgical procedure to implant a BRYAN® Cervical Disc is similar in approach and technique to traditional cervical spine surgery that has been used for more than five decades. A small incision, usually less than an inch long, is made in the skin of the neck just off the midline of the spine. Vital structures like nerves, arteries and the esophagus (the tube that connects the mouth and the stomach) are gently pulled out of the way so the surgeon can have access to the spine. The disc is removed using a microscope and surgical instruments made for this purpose. Once the disc has been safely removed in its entirety, the empty disc space is prepared by milling or shaping the endplates (bottom of each vertebrae) to incorporate the BRYAN® Cervical Disc device. The artificial disc is placed while the disc space between the two vertebrae (the bones of the spine) is held open. Once firmly in place, tension is taken off the vertebral bodies above and below compressing the artificial disc and holding it in place. Both surfaces of the BRYAN® cervical Disc are made of porous beaded cobalt metal that will incorporate and encourage bony ingrowth for long-term stability. The metal endplates surround a polyethylene core and saline cushion. Care and restrictions following surgery, as well as potential complications, are similar to those that occur with spinal fusion. See Fluoroscopy of BRYAN® Cervical Disc in Action BRYAN® is a trademark of Medtronic Sofamor DanekAn Alternative to Traditional Spinal FusionAge, genetics and everyday wear-and-tear of routine activities eventually can contribute to damage and degeneration of the discs that cushion the bones of the spine (the vertebrae). To treat degenerative disc disease, doctors usually begin with conservative (nonsurgical) medical treatment. When conservative therapy fails, other approaches, possibly including surgery, may be recommended. Currently, the gold standard for surgical treatment of problematic degenerative disc disease is spinal fusion. This procedure attempts to permanently lock two or more spinal vertebrae together so they cannot move except as a single unit. This may alleviate pain in a motion segment. Spinal fusion, however, has well known potential disadvantages, including:
How a Disc Is ReplacedSurgeons at Cedars-Sinai Institute for Spinal Disorders are at the forefront of the evaluation of a safe and effective artificial disc. The evolution for hip and knee replacement has taken more than 40 years to reach its current stage of technology in materials, design and technique. Although the idea of an artificial disc is not new, artificial disc replacement technology has just in the recent decade become mature enough to be used clinically in extensive testing in Europe . The unique biomechanical challenges of artificial disc replacement have presented a challenge of both design and material. In both traditional disc surgery and artificial disc replacement the procedure begins by removing the gelatinous disc between the vertebrae. A Program of Excellence in Artificial Disc Replacement (ADR)While hip and knee joint replacement surgery or arthroplasty has grown increasingly common since its advent in the early 1960s with a high degree of patient satisfaction, spine arthroplasty (or artificial disc replacement) has not been a viable option in the United States until recently. The challenge has been to develop a suitable replacement for the intervertebral discs. The replacement must not only be safe to implant, reliable and long lasting, it also must have the ability to mimic the complex range of movement required of a disc implant. Efforts to find a solution to these challenges have been ongoing for more than 40 years. Several artificial disc replacements for both the neck (cervical) and back (lumbar) spine are currently being offered to appropriate candidates at select U.S. centers. Cedars-Sinai Institute for Spinal Disorders is one of several medical center facilities on the West Coast involved in a Food and Drug Administration-approved study to implant, evaluate and study two new artificial disc implants - the BRYAN® and the Charité SB-III artificial discs for the neck and the back, respectively. Cedars-Sinai spine surgeons have successfully implanted more than 200 devices for the treatment of degenerative disc disease. Advantages of a Center of Excellence for Motion PreservationAs the West Coast medical center leader, Cedars-Sinai Institute for Spinal Disorders remains poised at the forefront in experience, expertise and patient satisfaction. We continually strive to provide safe and effective advances in spine surgery to give patients the greatest benefits and satisfaction possible. Our exceptionally well trained staff of both orthopedic and neurosurgery fellowship-trained surgeons (as well as other nonsurgical specialists) provides a unique multidisciplinary approach to ensure our patients the highest standards in spine care and treatment. Clinical TrialsProtocol Title: Safety and Effectiveness of the Bryan® Cervical Disc Prosthesis in the Treatment of Degenerative Disc Disease Working Title: A study of the use of the artificial disc as an alternative to spinal fusion in the surgical treatment of single level cervical disc problems Principal Investigator: J. Patrick Johnson, MD IRB Approval Number: 3972 Medical Specialty Area: Neurological and Orthopedic spine surgery Condition Disease: The treatment of degenerative cervical disc disease IRB Approval Expiration Date: 06/30/2006 Contact Information for patients wishing more information: Name: Lisa Armstrong RN Phone: (310) 423-9765 or 9900 |
